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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Blood Volume Measuring
510(k) Number K261099
Device Name Blood Volume Analyzer (200)
Applicant
Daxor Corporation
107 Meco Ln.
Oak Ridge,  TN  37830
Applicant Contact Jonathan Feldschuh
Correspondent
Daxor Corporation
107 Meco Ln.
Oak Ridge,  TN  37830
Correspondent Contact Jonathan Feldschuh
Regulation Number864.5950
Classification Product Code
JWO  
Subsequent Product Code
NNI  
Date Received04/02/2026
Decision Date 06/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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